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Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia

ConditionsIron-deficiency Anemia (IDA)HemoglobinIron DeficienciesAdverse Effect
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital General de Mexico

About this trial

The goal of this study is to compare ferrous salt and liposomal iron for the treatment of iron-deficiency anemia in adult women. The study will also evaluate how well each treatment is tolerated.

The main questions this study aims to answer are:

Does liposomal iron increase hemoglobin levels as effectively as ferrous salt?

Are there differences in side effects, especially gastrointestinal symptoms, between the treatments?

Does dosing ferrous salt every other day improve tolerance compared to daily dosing?

Researchers will compare three oral iron treatment strategies to determine which approach provides the best balance between effectiveness and tolerability.

Participants will:

Be adult women diagnosed with iron-deficiency anemia

Be randomly assigned to one of three groups:

Daily ferrous salt Ferrous salt taken every other day Daily liposomal iron Take the assigned iron treatment for 3 months Have blood tests at the beginning and end of the study to measure hemoglobin and iron levels Report any side effects or intolerance during treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients of reproductive age (15 to 49 years) with a diagnosis of iron-deficiency anemia secondary to dysfunctional uterine bleeding.

Patients with iron-deficiency anemia who are treatment-naïve or whose last administration of iron therapy, either oral or parenteral, occurred at least three months prior to enrollment and who continue to have anemia.

Patients with a functional oral route.

Signed informed consent.

Disqualifiers

Patients with abnormal uterine bleeding secondary to cancer

Severe intolerance to iron supplementation

Patients with gastritis or chronic use of proton pump inhibitors

Concomitant treatment with dietary supplements rich in calcium, magnesium, or zinc

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral ferrous fumarate administered every 24 hours

    Drug

    Administration of ferrous fumarate (each dose contains elemental iron, usually approximately 60 mg, together with ascorbic acid (vitamin C) in an amount of approximately 30 mg. In addition, it includes folic acid at a dose of approximately 400 mcg and vitamin B12 at approximately 8 mcg. Additional inactive ingredients may include excipients and coating agents to facilitate administration and absorption), administered every 24 hours. Participants are instructed to take one tablet or capsule per day, preferably with food to improve absorption and minimize potential gastrointestinal discomfort. The duration of treatment is three months for the recovery of anemia.

  • Ferrous fumarate administered orally every 48 hours.

    Drug

    Administration of ferrous fumarate (each dose contains elemental iron, usually approximately 60 mg, together with ascorbic acid (vitamin C) in an amount of approximately 30 mg. In addition, it includes folic acid at a dose of approximately 400 mcg and vitamin B12 at approximately 8 mcg. Additional inactive ingredients may include excipients and coating agents to facilitate administration and absorption), administered every 48 hours.

  • Liposomal iron formulation.

    Drug

    Administration of an oral supplement combining liposomal iron (19.20 mg of elemental iron), vitamin C (60 mg), and soluble fiber (350 mg). The formulation includes dehydrated glucose syrup, soluble corn fiber, iron in the form of ferric pyrophosphate, natural strawberry flavor, along with vitamins and coloring agents such as beet red and carminic acid. The combination of liposomal iron, vitamin C, and soluble fiber is designed to enhance iron absorption in the body, facilitating its utilization in hemoglobin synthesis and other essential components. The supplement is administered orally once daily (every 24 hours) for a duration of three months.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Oral ferrous fumarate administered every 24 hoursActive comparator 2 interventions
Group B: Ferrous fumarate administered orally every 48 hours.Active comparator 2 interventions
Group C: Liposomal iron formulation.Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline to 3 months in hemoglobin level (g/dL)

Hemoglobin concentration will be measured at baseline and at 3 months after initiation of treatment. A favorable response will be defined as an increase of at least 2 g/dL from baseline.

Time frame
Baseline and month 3

Secondary outcomes

1

Proportion of participants with any adverse event (%)

Proportion of participants experiencing at least one adverse event during treatment, graded according to CTCAE.

Time frame
Up to 3 months
2

Proportion of participants with specific adverse events (%)

Proportion of participants experiencing nausea, vomiting, abdominal pain, diarrhea, and constipation during treatment, graded according to CTCAE.

Time frame
Up to 3 months
3

Proportion of participants with intolerance to iron supplementation (%)

Proportion of participants who develop intolerance to iron supplementation, stratified by formulation (ferrous fumarate and liposomal iron).

Time frame
Up to 3 months
4

Proportion of participants who discontinue treatment (%)

Proportion of participants who discontinue iron supplementation, stratified by formulation.

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital General de Mexico

Lead sponsor

Hospital General de México Dr. Eduardo Liceaga

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: